Evaluation of Surface Refractive Index Shift of Kalifilcon A Lenses Compared to Dailies Total 1, Precision 1 and Biotrue ONEday Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Surface Refractive Index Shifts at 5 Minutes
研究概览
简要总结
Approximately 20 habitual soft contact lens wearing participants will be enrolled in this unilateral, randomized, double-masked (participant and investigator masked) repeated measures insertion study. All participants will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If participants satisfy all eligibility criteria and none of the exclusion criteria, subjects will insert study lenses in random, successive order according to unique randomization schedules that will be provided to each Investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older and have full legal capacity to volunteer.
- •Physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •No active ocular disease or allergic conjunctivitis.
- •Not using any topical ocular medications.
- •Willing and able to follow instructions.
- •Signed a statement of informed consent.
排除标准
- •Participating in a conflicting study in the opinion of the Investigator.
- •Considered by the Investigator to not be a suitable candidate for participation.
结局指标
主要结局
Surface Refractive Index Shifts at 5 Minutes
时间窗: 5 minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Surface Refractive Index Shifts at 15 Minutes
时间窗: 15 minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
Surface Refractive Index Shifts at 10 Minutes
时间窗: 10 minutes
Refractive index is the ratio of velocity of light in a material divided with velocity of light in vacuum. The eye was measured for surface refractive index on the refractometer. The refractive index of a medium is the ratio of the speed of light in vacuum to the speed of light in the medium. It has no units.
次要结局
未报告次要终点